2013 OHSUG - Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

7/27/2019 2013 OHSUG - Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

1/24

PREVIOUS NEXT

PREVIOUS NEXT

Merging Multiple Drug Safety and Pharmacovigilance

Databases into One Global Oracle Argus Safety System

Facilitating Globalization with Automated Configuration Loading

July 26, 2013

Rodney Lemery, MPH, PhDVice President, Safety andPharmacovigilance

BioPharm Systems, Inc.


2/24

PREVIOUS NEXT

Agenda

Summary of Situation

Project Overview

Review of Database Architecture Technical Overview

Description of Methods Used

Origin of Methodology

Techniques Used

Results of Methods

Lessons Learned

What This Means for You


3/24

PREVIOUS NEXT

Summary of Situation

Project Overview

A leading U.S.-based pharmaceutical company founded in the early 1980s

issued a RFP asking for assistance in the globalization of their current

Argus Safety system

The company would be migrating three separate non-Argus safetyapplications into their central Argus database

To accommodate this migration, configuration of the data not currently

present in the global repository needs to be entered and present before

any meaningful mapping discussions could be final and executed


4/24

PREVIOUS NEXT

Methods Used

Origin of Methods

Argus installations contain an

Oracle DUMP (DMP) file that

contains a number of database

tables pre-populated with thestandard data that ships with

the initial Argus application

BioPharm reviewed the

associated LOG files to identify

tables that were manipulatedby the vendor


5/24

PREVIOUS NEXT

Methods Used

Origin of Methods

Unfortunately, the desired list maintenance (LM) tables (such as

products, licenses, etc.) were not present in the DMP file

However, BioPharm does see the use of a DMP file as vendor

precedence for the use of data manipulation language (DML) in

configuration tables of the Argus database

Also, in our past Argus migration work, the required extract,

transformation and loading tools included DML use in the Argus backend


6/24

PREVIOUS NEXT

Methods Used

Technique Overview


7/24PREVIOUS NEXT

Methods Used


8/24PREVIOUS NEXT

Methods Used

Techniques Used

Given that we interface with mostly safety business users and the fact

that this configuration methodology and work is technical in nature, we

have devised a configuration requirements specifications (CRS)

document to fully document the required elements of configuration

This MS Excel document is populated with the required elements

necessary in full configuration table population


9/24PREVIOUS NEXT

Methods Used

Techniques Used

We identified the mandatory field data in the required tables and reflected

those fields in the CRS document

Meetings were then facilitated to discuss the information in the CRS andreach consensus to its content


10/24PREVIOUS NEXT

Methods Used

Techniques Used

Since all of the Argus native constraints were kept active in the database, we

needed to reflect that constraint logic in the Excel file to ensure minimum

negative database impact

Sometimes, constraints were enforced by the Argus application and NOT thedatabase


11/24PREVIOUS NEXT

Methods Used


12/24PREVIOUS NEXT

Methods Used

Techniques Used

For mass loading of data,

BioPharm used the SQL*Ldr

application available from

Oracle as part of an advancedSQL*Net installation

This application requires the

creation of a control (CTL) file

that describes what file should

be uploaded into what table This file also contains

descriptions of the columns

expected in the source data file

and maps it to the

corresponding Argus table


13/24PREVIOUS NEXT

Methods Used

Techniques Used

The corresponding CRS tab was then saved into a corresponding CSV file

referred to in the control file above


14/24PREVIOUS NEXT

Methods Used

Techniques Used

Many of the populated tables, such as LM_PRODUCTS, required a number

of decoded fields from the database (such as concentration units,

formulation, etc.) prior to insertion (foreign key lookups)

While we could have placed those required IDs in the CRS directly, thevolume of information would have been very challenging to manage

We opted instead to use SQL*Ldr to load the more complex data into

temporary staging tables where a helper PL/SQL Package was used to

code the required information by executing a series of lookup functions

to return the required ID fields that are required to adhere to referentialintegrity


15/24PREVIOUS NEXT

Methods Used


16/24PREVIOUS NEXT

Methods Used

Techniques Used

SQL*Ldr can be executed through the standard MS Command line

interface on any windows machine

The execution command requires the control file


17/24PREVIOUS NEXT

Methods Used


18/24PREVIOUS NEXT

Methods Used

Assumptions and Risks to Remember with this Methodology

The BioPharm methods explained here do NOTdisable the native

constraints and triggers used by the Argus database

All information loaded into the tables must comply with these native

table constraints

There is a possibility that certain Argus application level triggers or

constraints are being bypassed in this methodology beyond those

already identified within these slides


19/24

PREVIOUS NEXT

Methods Used


20/24

PREVIOUS NEXT

Methods Used

OQ/PQ Testing

Once the CRS is final, BioPharm suggest documenting the user

requirements in a separate document referred to as a User Requirements

Specification (URS)

This document should contain all of the high-level requirements for the

globalization of the system including any major aspects of the system

that the users are concerned over given the risks of using a database

level loading of configuration


21/24

PREVIOUS NEXT

Results

Impact on Globalization

Saved ~39 days in

configuration

work

Empowered the

company to reuse

the scripting in

future

globalization

efforts

Configuration Type ConfigurationItem CountEstimated

Manual

Time

Actual

Load

Time

SavedTime

Products 1789 7.5 0.008 7.492

Ingredients 1927 2 0.008 1.992

Licenses 4242 26.5 0.008 26.492

Datasheets 1178 1.2 0.008 1.192

Reporting Rules 156 1 0.008 0.992

E2B Receivers 70 0.6 0.008 0.592

E2B Senders 68 0.6 0.008 0.592

Manufacturers 57 0.1 0.008 0.092

TOTALS 9487 39.5 0.063 39.436

Table 1: Estimated Time Savings From Configuration

Development Scripts (all time in days)


22/24

PREVIOUS NEXT

Lessons Learned

Improvements for Next time

MS Excel constraint and lookup columns were not always hidden from

user view when reviewing this complex document and should have been

As many decisions on the data in the CRS were driven by Argus business

use, importance should be placed in how the application is to be used

before configuration data is uploaded

All end-users should actively participate in these decision discussions as

the data will impact their entry, management and analysis of safety

information

Automation of the CSV files from the MS Excel sheets


23/24

PREVIOUS NEXT

Ways to Engage

For those ready

Proof of concept

For those not quite ready

Schedule early engagement calls to provide guidance on similar projects

For those in the midst of a globalization

Refine your approach with guidance calls to review your approach and

evaluate ifBioPharms methods might be useful to your organization

What this means for you?


24/24

Questions & Answers

2000 Alameda de las PulgasSuite 154

San Mateo, CA 94403-1270

www.biopharm.com

Rodney L. Lemery MPH, PhDVice Pres. Safety and PV

Tel (650) 292-5310

Fax (650) 292-5301

[email protected]
http://www.biopharm.com/mailto:[email protected]:[email protected]://www.biopharm.com/

Documents

2013 OHSUG - Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System